The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Fourth Gas Module With Co2 For Primus Us Apollo.
| Device ID | K081447 |
| 510k Number | K081447 |
| Device Name: | FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL AG & CO. KG 53/55 MOISLINGER ALLEE Luebeck, DE 23542 |
| Contact | Karin Luebbers |
| Correspondent | Karin Luebbers DRAEGER MEDICAL AG & CO. KG 53/55 MOISLINGER ALLEE Luebeck, DE 23542 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-22 |
| Decision Date | 2008-10-08 |
| Summary: | summary |